{"success":true,"data":{"pressRelease":{"id":"16820","rtpr_id":"nGNX4N4DY9","ticker":"AXSM","exchange":"NASDAQ","all_tickers":["AXSM"],"title":"Axsome Therapeutics Hosts AUVELITY® FDA Approval Investor Event Featuring Expert Thought Leader","author":"Globe Newswire","published_at":"2026-05-01T11:15:00.134Z","article_body":"NEW YORK, May 01, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:\nAXSM), a biopharmaceutical company leading a new era in the treatment of\ncentral nervous system (CNS) disorders, will host a virtual investor event and\nconference call today at 8:00 AM Eastern Time to discuss the U.S. Food and\nDrug Administration (FDA) approval of AUVELITY(®) (dextromethorphan HBr and\nbupropion HCl) for the treatment of agitation associated with dementia due to\nAlzheimer’s disease.(1) AUVELITY is a first-in-class treatment for\nAlzheimer’s disease agitation which targets the N-methyl D-aspartate (NMDA)\nand sigma-1 receptors.\n\nOn the call, Dr. Jeffrey Cummings, Chambers-Grundy Professor of Brain\nSciences, UNLV Kirk Kerkorian School of Medicine, will provide an overview of\nAlzheimer’s disease agitation, its current treatment landscape, and share\nhis clinical perspective on AUVELITY in the indication. The Axsome management\nteam will provide an overview of AUVELITY and anticipated commercial plans.\nThe presenters will be available to answer questions at the end of the\npresentation. To access the live webcast, please click here.\n\nExperience the interactive FDA-Approval Multimedia News Release here\n(https://www.globenewswire.com/Tracker?data=us7w7fe6UdM8jaRl_G991cNqfttKiV-VT8QtxKqqPYHJY6Ls3zkC2psH7QBy0DnejWZHq5wfB0ziNIFDIchMbDOBZqpUp3Jo8jBbBAgrvwEXXfu7t8QuFFrGQ3-zdQrzvazrfxlLVl4rEuYSErTOYhkCFBfLMQjD40g4wp3Fx-Y=).\n\nConference Call Information\n\nTo participate in the live conference call, please dial (877) 405-1239\n(toll-free domestic) or +1 (201) 389-0851 (international). A live webcast of\nthe conference call can be accessed on the “Webcasts & Presentations” page\nof the “Investors” section of the Company’s website at axsome.com. A\nreplay of the conference call will be available for approximately 30 days\nfollowing the live event.\n\nAbout Agitation Associated with Dementia Due to Alzheimer’s Disease\n\nAlzheimer’s disease is the most common form of dementia affecting more than\n7 million people in the U.S.(2) Agitation associated with dementia due to\nAlzheimer’s disease is a neuropsychiatric condition reported in up to 76% of\npatients with Alzheimer’s disease and is characterized by emotional\ndistress, verbal and physical aggressiveness, disruptive irritability, and\ndisinhibition.(2,3) The exact cause of agitation in the brain is not known\nbut it is associated with changes in glutamate and monoamine signaling.(4,5)\nAgitation has been associated with accelerated cognitive decline, increased\ncaregiver burden, and increased mortality risk, and is a leading cause of\nassisted living or nursing home placement.(6)\n\nAbout AUVELITY\n\nAUVELITY (dextromethorphan HBr/bupropion HCl) is an oral N-methyl-D-aspartate\n(NMDA) receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor.\nAUVELITY is a first-in-class medicine, with a distinct mechanism of action,\nfor the treatment of agitation associated with dementia due to Alzheimer’s\ndisease. AUVELITY was initially approved by the U.S. FDA in 2022 for the\ntreatment of major depressive disorder (MDD) in adults, and it is the first\nand only rapid-acting oral treatment approved with labeling of statistically\nsignificant improvement in depressive symptoms compared to placebo, starting\nat one week, for the treatment of MDD. AUVELITY is protected by a robust\npatent estate extending to at least 2043.\n\nINDICATION AND IMPORTANT SAFETY INFORMATION\n\nWHAT IS AUVELITY (aw-VEHL-ah-tee)? It is a prescription oral medicine used to\ntreat adults with major depressive disorder (MDD) and agitation that may\nhappen with dementia due to Alzheimer’s disease (AAD). AUVELITY should not\nbe used as an “as needed” treatment for agitation that may happen with\ndementia due to Alzheimer’s disease.\n\nIt is not known if AUVELITY is safe and effective in children with MDD.\n\nWHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT AUVELITY?\n\nAUVELITY and other antidepressant medicines may increase suicidal thoughts and\nactions in some children, adolescents, and young adults, especially within the\nfirst few months of treatment or when the dose is changed. AUVELITY is not for\nuse in children.\n\nYou should pay close attention to any new or sudden changes in mood, behavior,\nthoughts, or feelings or if you develop suicidal thoughts or actions. This is\nvery important when starting or changing the dose of an antidepressant\nmedicine.\n\nCall your healthcare provider (HCP) or get emergency help right away if you or\nyour loved one have any of the following symptoms, especially if they are new,\nworse, or worry you:\n* suicidal thoughts or actions\n* new or worsening depression or anxiety\n* agitation or restlessness\n* trouble sleeping (insomnia)\n* acting aggressive, being angry, or violent\n* an extreme increase in activity and talking (mania)\n* panic attacks\n* new or worsening irritability\n* acting on dangerous impulses\n* other unusual changes in behavior or mood\nDo not take AUVELITY if you:\n* have or had a seizure disorder.\n* have or had an eating disorder like anorexia or bulimia.\n* have recently and suddenly stopped drinking alcohol or use medicines called\nbenzodiazepines, barbiturates, or anti-seizure medicines, and you have\nrecently suddenly stopped taking them.\n* are taking a monoamine oxidase inhibitor (MAOI), have stopped taking an MAOI\nin the last 14 days, or are being treated with the antibiotic linezolid or\nintravenous methylene blue. Ask your HCP or pharmacist if you are unsure\nwhether you take an MAOI. Do not start taking an MAOI until you have stopped\ntaking AUVELITY for at least 14 days.\n* are allergic to dextromethorphan, bupropion, or any other ingredients in\nAUVELITY.\nAUVELITY may cause serious side effects. Ask your HCP how to recognize the\nserious side effects below and what to do if you think you have one:\n\nSeizures. There is a risk of seizures during treatment with AUVELITY. The risk\nis higher if you take higher doses of AUVELITY, have certain medical problems,\nor take AUVELITY with certain other medicines. Do not take AUVELITY with other\nmedicines unless your healthcare provider tells you to.\n\nIf you have a seizure during treatment with AUVELITY, stop taking AUVELITY and\ncall your HCP right away. Do not take AUVELITY again if you have a seizure.\n\nIncreases in blood pressure (hypertension). Some people may get high blood\npressure during treatment with AUVELITY. Your HCP should check your blood\npressure before you start taking and during treatment with AUVELITY.\n\nManic episodes. Manic episodes may happen in people with bipolar disorder who\ntake AUVELITY. Symptoms may include:\n* greatly increased energy\n* racing thoughts\n* unusually grand ideas\n* talking more or faster than usual\n* severe trouble sleeping\n* reckless behavior\n* excessive happiness or irritability\nUnusual thoughts or behaviors. One of the ingredients in AUVELITY (bupropion)\ncan cause unusual thoughts or behaviors, including delusions (believing you\nare someone else), hallucinations (seeing or hearing things that are not\nthere), paranoia (feeling that people are against you), or feeling confused.\nIf this happens to you, call your HCP.\n\nEye problems (angle-closure glaucoma). AUVELITY may cause a type of eye\nproblem called angle-closure glaucoma in people with certain other eye\nconditions. You may want to undergo an eye examination to see if you are at\nrisk and receive preventative treatment if you are. Call your HCP if you have\neye pain, changes in your vision, or swelling or redness in or around the eye.\n\nDizziness. AUVELITY may cause dizziness which may increase your risk for\nfalls.\n\nSerotonin syndrome. A potentially life-threatening problem called serotonin\nsyndrome can happen when you take AUVELITY with certain other medicines. Call\nyour HCP or go to the nearest hospital emergency room right away if you have\nany of the following signs and symptoms:\n* agitation\n* hallucinations\n* confusion\n* coma\n* fast heartbeat\n* blood pressure changes\n* dizziness\n* sweating\n* flushing\n* high body temperature (hyperthermia)\n* shaking (tremors), stiff muscles, or muscle twitching\n* loss of coordination\n* seizures\n* nausea, vomiting, diarrhea\nHyponatremia. Low sodium levels in the blood, sometimes severe and causing\ndeath, have occurred as a result of treatment with AUVELITY. Elderly patients\nmay be at greater risk. Low sodium levels could be the result of a condition\ncalled syndrome of inappropriate antidiuretic hormone secretion (SIADH).\nTaking AUVELITY with antidepressants called SSRIs may increase the risk. Stop\ntaking AUVELITY and call your HCP or go to the nearest hospital emergency room\nright away if you have any of the following signs or symptoms: headache,\ndifficulty concentrating, memory loss, confusion, weakness and unsteadiness\nwhich can lead to falls.\n\nCOMMON SIDE EFFECTS\n\nThe most common side effects of AUVELITY when treating MDD include dizziness,\nheadache, diarrhea, feeling sleepy, dry mouth, sexual function problems, and\nexcessive sweating.\n\nThe most common side effects of AUVELITY when treating agitation that may\nhappen with dementia due to Alzheimer’s disease include dizziness and\nindigestion.\n\nThese are not all the possible side effects of AUVELITY. Tell your doctor if\nyou have any side effects. You are encouraged to report side effects of\nprescription drugs to the FDA. Visit www.fda.gov/medwatch, or call\n1–800-FDA-1088.\n\nBEFORE USING\n* Tell your HCP about all the medicines you take, including prescription and\nover-the-counter medicines, vitamins, and herbal supplements.\n* It is important to tell your HCP if you are taking: * other medicines\ncontaining bupropion or dextromethorphan\n* medicines to treat depression, anxiety, psychotic or thought disorders,\nincluding selective serotonin reuptake inhibitors (SSRIs) and tricyclic\nantidepressants\n* theophylline\n* corticosteroids\n* oral diabetes medicines or use insulin to control your blood sugar\n* medicines to control appetite (anorectic)\n* nicotine medicines to help you stop smoking\n* street (illicit) drugs\n* benzodiazepines, sedative-hypnotic (sleep medicines), or opiates\n \n* If you are unsure if you take any of these medicines, ask your HCP. They can\ntell you if it is safe to take AUVELITY with your other medicines.\n* Tell your HCP if you are pregnant or plan to become pregnant. AUVELITY may\nharm your unborn baby if you take it during pregnancy. AUVELITY is not\nrecommended during pregnancy. Your HCP will prescribe another treatment for\nfemales who plan to become pregnant.\n* One of the ingredients in AUVELITY passes into your breast milk. Do not\nbreastfeed during treatment with AUVELITY and for 5 days after the final dose.\nTell your HCP about all your medical conditions, including if you:\n* have problems with your liver or kidneys.\n* have diabetes, heart disease, or high blood pressure.\n* have a history of seizure, stroke, eating disorder, head injury, or have a\ntumor in your brain or spinal cord.\n* have a history of alcohol or drug abuse.\n* have a history of seizure, eating disorder, or abuse alcohol or drugs.\n* have low blood sugar, low blood sodium levels, or a history of falls.\n* you take certain other medicines that could interact with AUVELITY.\n* have or had a condition known as bipolar disorder, a family history of\nbipolar disorder, suicide, or depression.\n* have high pressure in the eye (glaucoma).\nReview the list below with your HCP. AUVELITY may not be right for you if:\n* you drink a lot of alcohol.\n* you abuse prescription or street drugs.\n* you are pregnant or plan to become pregnant.\n* you are breastfeeding or plan to breastfeed.\nHOW TO TAKE\n* Take AUVELITY exactly as instructed by your HCP.\n* MDD: Take AUVELITY 45 mg/105 mg once daily in the morning for 3 days. On Day\n4, increase to the maximum recommended dosage of AUVELITY 45 mg/105 mg twice a\nday, taken at least 8 hours apart. Do not take more than 2 AUVELITY tablets in\n24 hours.\n* AAD: * Take 1 AUVELITY 30 mg/105 mg tablet once daily in the morning for 7\ndays.\n* On Day 8, increase to AUVELITY 30 mg/105 mg twice a day, taken at least 8\nhours apart. Do not take more than 2 AUVELITY tablets in 24 hours.\n* On Day 15 after starting AUVELITY, increase to the maximum recommended\ndosage of AUVELITY 45 mg/ 105 mg twice a day, taken at least 8 hours apart,\nbased on tolerability. Do not take more than 2 AUVELITY tablets in 24 hours.\n \n* If you miss a dose, do not take an extra dose. Wait and take your next dose\nat the regular time. Do not take more than 1 dose of AUVELITY at a time.\n* Do not change your dose or stop taking AUVELITY without talking to your HCP.\n* Swallow AUVELITY tablets whole. Do not crush, chew, or divide the tablets.\n* Do not give AUVELITY to other people.\n* If you take too much AUVELITY call your poison control center at\n1-800-222-1222 or go to the nearest hospital emergency room right away.\nLEARN MORE\n\nFor more information about AUVELITY, call 866-496-2976 or visit AUVELITY.com.\n\nThis summary provides basic information about AUVELITY but does not include\nall information known about this medicine. Read the information that comes\nwith your prescription each time your prescription is filled. This information\ndoes not take the place of talking with your doctor. Be sure to talk to your\ndoctor or other HCP about AUVELITY and how to take it. Your HCP is the best\nperson to help you decide if AUVELITY is right for you.\n\nAUVELITY is available as 30 mg dextromethorphan/105 mg bupropion and 45 mg\ndextromethorphan/105 mg bupropion tablets.\n\nAUC CON BS 04/2026\n\nPlease see full Prescribing Information\n(https://www.globenewswire.com/Tracker?data=0l5wIE40rmE9xGJfjJuQDWCuCKqWN2TyCsnOsYO7ESIncqwqkDUVMdZ6XwERo3Sy9Qmlp7vWXFp6ryUMVTJjKs4QilXB65PYxji1OiAUczdqF7wWi5dR23U2NY2udMsJooa0dGN60V38G-zGA7IHlkfI38MC_POIEsyhqRA1Gw5Hd-ivCsHIqWwlw4oBHOGS),\nincluding Boxed Warning for suicidal thoughts and behaviors, and Medication\nGuide\n(https://www.globenewswire.com/Tracker?data=THgpvspI8A7y8hafxrXS0LZET-PkvEuPYMpIUMgG1WA9fUjup_2LYr57Yq3JGwlzbDO0eCBIq2TLywbL_wQkFCa_qjutDDoIC3EOhuKMCC_F3aFlikWRIs-s4jmfBsHmiKLKOYGmAP4HUTJ9PNrUnV5zSUa7agolSKZMzpZ7ecs=).\n\nAbout Axsome Therapeutics\n\nAxsome Therapeutics is a biopharmaceutical company leading a new era in the\ntreatment of central nervous system (CNS) conditions. We deliver scientific\nbreakthroughs by identifying critical gaps in care and develop differentiated\nproducts with a focus on novel mechanisms of action that enable meaningful\nadvancements in patient outcomes. Our industry-leading neuroscience portfolio\nincludes FDA-approved treatments for agitation associated with dementia due to\nAlzheimer’s disease, major depressive disorder, excessive daytime sleepiness\nassociated with narcolepsy and obstructive sleep apnea, and migraine, and\nmultiple late-stage development programs addressing a broad range of serious\nneurological and psychiatric conditions that impact over 150 million people in\nthe United States. Together, we are on a mission to solve some of the\nbrain’s biggest problems so patients and their loved ones can flourish. For\nmore information, please visit us at www.axsome.com and follow us on LinkedIn\n(https://www.globenewswire.com/Tracker?data=MIkG-v4wBZxR6N73NJvVv0wr3_Ml8VZsQrNHO41YRBqWwdFLRhufmlaPESchOOaVuvYBlFJemV0_2JN5viLqcTnyeCeXURtn-G0JQiDyqEo=)\nand X\n(https://www.globenewswire.com/Tracker?data=dMbNclo--mYTB7xEd5sy1LsPRPOto4l4vAkh2Php822oAlGL5WgfhBHa4S5UKjl0AsCXVCod-AvHxU6fGWGUrg==).\n\nForward Looking Statements\n\nCertain matters discussed in this press release are “forward-looking\nstatements”. The Company may, in some cases, use terms such as\n“predicts,” “believes,” “potential,” “continue,”\n“estimates,” “anticipates,” “expects,” “plans,” “intends,”\n“may,” “could,” “might,” “will,” “should” or other words\nthat convey uncertainty of future events or outcomes to identify these\nforward-looking statements. In particular, the Company’s statements\nregarding trends and potential future results are examples of such\nforward-looking statements. The forward-looking statements include risks and\nuncertainties, including, but not limited to, the commercial success of the\nCompany’s SUNOSI(®), AUVELITY(®), and SYMBRAVO(®) products and the\nsuccess of the Company’s efforts to obtain any additional indication(s) with\nrespect to solriamfetol and/or AXS-05; the Company’s ability to maintain and\nexpand payer coverage; the success, timing and cost of the Company’s ongoing\nclinical trials and anticipated clinical trials for the Company’s current\nproduct candidates, including statements regarding the timing of initiation,\npace of enrollment and completion of the trials (including the Company’s\nability to fully fund the Company’s disclosed clinical trials, which assumes\nno material changes to the Company’s currently projected revenues or\nexpenses), futility analyses and receipt of interim results, which are not\nnecessarily indicative of the final results of the Company’s ongoing\nclinical trials, and/or data readouts, and the number or type of studies or\nnature of results necessary to support the filing of a new drug application\n(“NDA”) for any of the Company’s current product candidates; the\nCompany’s ability to fund additional clinical trials to continue the\nadvancement of the Company’s product candidates; the timing of and the\nCompany’s ability to obtain and maintain U.S. Food and Drug Administration\n(“FDA”) or other regulatory authority approval of, or other action with\nrespect to, the Company’s product candidates, including statements regarding\nthe timing of any NDA submission; the Company’s ability to successfully\ndefend its intellectual property or obtain the necessary licenses at a cost\nacceptable to the Company, if at all; the Company’s ability to successfully\nresolve any intellectual property litigation, and even if such disputes are\nsettled, whether the applicable federal agencies will approve of such\nsettlements; the successful implementation of the Company’s research and\ndevelopment programs and collaborations; the success of the Company’s\nlicense agreements; the acceptance by the market of the Company’s products\nand product candidates, if approved; the Company’s anticipated capital\nrequirements, including the amount of capital required for the\ncommercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s\ncommercial launch of its other product candidates, if approved, and the\npotential impact on the Company’s anticipated cash runway; the Company’s\nability to convert sales to recognized revenue and maintain a favorable gross\nto net sales; unforeseen circumstances or other disruptions to normal business\noperations arising from or related to domestic political climate,\ngeo-political conflicts or a global pandemic and other factors, including\ngeneral economic conditions and regulatory developments, not within the\nCompany’s control. The factors discussed herein could cause actual results\nand developments to be materially different from those expressed in or implied\nby such statements. The forward-looking statements are made only as of the\ndate of this press release and the Company undertakes no obligation to\npublicly update such forward-looking statements to reflect subsequent events\nor circumstances.\n\nInvestors:\nAshley Dong\nSenior Director, Investor Relations\n(929) 687-1614\nadong@axsome.com\n\nMedia:\nDarren Opland\nSenior Director, Corporate Communications\n(929) 837-1065\ndopland@axsome.com\n\nReferences:\n1. AUVELITY [Prescribing Information]. New York, NY: Axsome Therapeutics, Inc.\n2. Alzheimer’s Association. 2025 Alzheimer’s Disease Facts and Figures.\n3. Van der Mussele, S. et al. Agitation-associated behavioral symptoms in mild\ncognitive impairment and Alzheimer's dementia. Aging Ment Health.\n2015;19(3):247-57.\n4. Cummings J.L., et al. An overview of the pathophysiology of agitation in\nAlzheimer's dementia with a focus on neurotransmitters and circuits. CNS\nSpectr 2024:1–10.\n5. Rosenberg P.B., et al. Neuropsychiatric symptoms in Alzheimer's disease:\nWhat might be associated brain circuits? Mol Aspects Med 2015;43-44:25–37.\n6. Porsteinsson, A.P. and Antonsdottir, I.M. An update on the advancements in\nthe treatment of agitation in Alzheimer’s disease. Expert Opin Pharmacother.\n2017 Apr;18(6):611-620.\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/1186f248-bfb6-4258-a391-f2ffd94c5d76)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX4N4DY9","title":"Axsome Therapeutics Hosts AUVELITY® FDA Approval Investor Event Featuring Expert Thought Leader","author":"Globe Newswire","ticker":"AXSM","created":"2026-05-01T11:15:00.134Z","tickers":["AXSM"],"exchange":"NASDAQ","article_body":"NEW YORK, May 01, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:\nAXSM), a biopharmaceutical company leading a new era in the treatment of\ncentral nervous system (CNS) disorders, will host a virtual investor event and\nconference call today at 8:00 AM Eastern Time to discuss the U.S. Food and\nDrug Administration (FDA) approval of AUVELITY(®) (dextromethorphan HBr and\nbupropion HCl) for the treatment of agitation associated with dementia due to\nAlzheimer’s disease.(1) AUVELITY is a first-in-class treatment for\nAlzheimer’s disease agitation which targets the N-methyl D-aspartate (NMDA)\nand sigma-1 receptors.\n\nOn the call, Dr. Jeffrey Cummings, Chambers-Grundy Professor of Brain\nSciences, UNLV Kirk Kerkorian School of Medicine, will provide an overview of\nAlzheimer’s disease agitation, its current treatment landscape, and share\nhis clinical perspective on AUVELITY in the indication. The Axsome management\nteam will provide an overview of AUVELITY and anticipated commercial plans.\nThe presenters will be available to answer questions at the end of the\npresentation. To access the live webcast, please click here.\n\nExperience the interactive FDA-Approval Multimedia News Release here\n(https://www.globenewswire.com/Tracker?data=us7w7fe6UdM8jaRl_G991cNqfttKiV-VT8QtxKqqPYHJY6Ls3zkC2psH7QBy0DnejWZHq5wfB0ziNIFDIchMbDOBZqpUp3Jo8jBbBAgrvwEXXfu7t8QuFFrGQ3-zdQrzvazrfxlLVl4rEuYSErTOYhkCFBfLMQjD40g4wp3Fx-Y=).\n\nConference Call Information\n\nTo participate in the live conference call, please dial (877) 405-1239\n(toll-free domestic) or +1 (201) 389-0851 (international). A live webcast of\nthe conference call can be accessed on the “Webcasts & Presentations” page\nof the “Investors” section of the Company’s website at axsome.com. A\nreplay of the conference call will be available for approximately 30 days\nfollowing the live event.\n\nAbout Agitation Associated with Dementia Due to Alzheimer’s Disease\n\nAlzheimer’s disease is the most common form of dementia affecting more than\n7 million people in the U.S.(2) Agitation associated with dementia due to\nAlzheimer’s disease is a neuropsychiatric condition reported in up to 76% of\npatients with Alzheimer’s disease and is characterized by emotional\ndistress, verbal and physical aggressiveness, disruptive irritability, and\ndisinhibition.(2,3) The exact cause of agitation in the brain is not known\nbut it is associated with changes in glutamate and monoamine signaling.(4,5)\nAgitation has been associated with accelerated cognitive decline, increased\ncaregiver burden, and increased mortality risk, and is a leading cause of\nassisted living or nursing home placement.(6)\n\nAbout AUVELITY\n\nAUVELITY (dextromethorphan HBr/bupropion HCl) is an oral N-methyl-D-aspartate\n(NMDA) receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor.\nAUVELITY is a first-in-class medicine, with a distinct mechanism of action,\nfor the treatment of agitation associated with dementia due to Alzheimer’s\ndisease. AUVELITY was initially approved by the U.S. FDA in 2022 for the\ntreatment of major depressive disorder (MDD) in adults, and it is the first\nand only rapid-acting oral treatment approved with labeling of statistically\nsignificant improvement in depressive symptoms compared to placebo, starting\nat one week, for the treatment of MDD. AUVELITY is protected by a robust\npatent estate extending to at least 2043.\n\nINDICATION AND IMPORTANT SAFETY INFORMATION\n\nWHAT IS AUVELITY (aw-VEHL-ah-tee)? It is a prescription oral medicine used to\ntreat adults with major depressive disorder (MDD) and agitation that may\nhappen with dementia due to Alzheimer’s disease (AAD). AUVELITY should not\nbe used as an “as needed” treatment for agitation that may happen with\ndementia due to Alzheimer’s disease.\n\nIt is not known if AUVELITY is safe and effective in children with MDD.\n\nWHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT AUVELITY?\n\nAUVELITY and other antidepressant medicines may increase suicidal thoughts and\nactions in some children, adolescents, and young adults, especially within the\nfirst few months of treatment or when the dose is changed. AUVELITY is not for\nuse in children.\n\nYou should pay close attention to any new or sudden changes in mood, behavior,\nthoughts, or feelings or if you develop suicidal thoughts or actions. This is\nvery important when starting or changing the dose of an antidepressant\nmedicine.\n\nCall your healthcare provider (HCP) or get emergency help right away if you or\nyour loved one have any of the following symptoms, especially if they are new,\nworse, or worry you:\n* suicidal thoughts or actions\n* new or worsening depression or anxiety\n* agitation or restlessness\n* trouble sleeping (insomnia)\n* acting aggressive, being angry, or violent\n* an extreme increase in activity and talking (mania)\n* panic attacks\n* new or worsening irritability\n* acting on dangerous impulses\n* other unusual changes in behavior or mood\nDo not take AUVELITY if you:\n* have or had a seizure disorder.\n* have or had an eating disorder like anorexia or bulimia.\n* have recently and suddenly stopped drinking alcohol or use medicines called\nbenzodiazepines, barbiturates, or anti-seizure medicines, and you have\nrecently suddenly stopped taking them.\n* are taking a monoamine oxidase inhibitor (MAOI), have stopped taking an MAOI\nin the last 14 days, or are being treated with the antibiotic linezolid or\nintravenous methylene blue. Ask your HCP or pharmacist if you are unsure\nwhether you take an MAOI. Do not start taking an MAOI until you have stopped\ntaking AUVELITY for at least 14 days.\n* are allergic to dextromethorphan, bupropion, or any other ingredients in\nAUVELITY.\nAUVELITY may cause serious side effects. Ask your HCP how to recognize the\nserious side effects below and what to do if you think you have one:\n\nSeizures. There is a risk of seizures during treatment with AUVELITY. The risk\nis higher if you take higher doses of AUVELITY, have certain medical problems,\nor take AUVELITY with certain other medicines. Do not take AUVELITY with other\nmedicines unless your healthcare provider tells you to.\n\nIf you have a seizure during treatment with AUVELITY, stop taking AUVELITY and\ncall your HCP right away. Do not take AUVELITY again if you have a seizure.\n\nIncreases in blood pressure (hypertension). Some people may get high blood\npressure during treatment with AUVELITY. Your HCP should check your blood\npressure before you start taking and during treatment with AUVELITY.\n\nManic episodes. Manic episodes may happen in people with bipolar disorder who\ntake AUVELITY. Symptoms may include:\n* greatly increased energy\n* racing thoughts\n* unusually grand ideas\n* talking more or faster than usual\n* severe trouble sleeping\n* reckless behavior\n* excessive happiness or irritability\nUnusual thoughts or behaviors. One of the ingredients in AUVELITY (bupropion)\ncan cause unusual thoughts or behaviors, including delusions (believing you\nare someone else), hallucinations (seeing or hearing things that are not\nthere), paranoia (feeling that people are against you), or feeling confused.\nIf this happens to you, call your HCP.\n\nEye problems (angle-closure glaucoma). AUVELITY may cause a type of eye\nproblem called angle-closure glaucoma in people with certain other eye\nconditions. You may want to undergo an eye examination to see if you are at\nrisk and receive preventative treatment if you are. Call your HCP if you have\neye pain, changes in your vision, or swelling or redness in or around the eye.\n\nDizziness. AUVELITY may cause dizziness which may increase your risk for\nfalls.\n\nSerotonin syndrome. A potentially life-threatening problem called serotonin\nsyndrome can happen when you take AUVELITY with certain other medicines. Call\nyour HCP or go to the nearest hospital emergency room right away if you have\nany of the following signs and symptoms:\n* agitation\n* hallucinations\n* confusion\n* coma\n* fast heartbeat\n* blood pressure changes\n* dizziness\n* sweating\n* flushing\n* high body temperature (hyperthermia)\n* shaking (tremors), stiff muscles, or muscle twitching\n* loss of coordination\n* seizures\n* nausea, vomiting, diarrhea\nHyponatremia. Low sodium levels in the blood, sometimes severe and causing\ndeath, have occurred as a result of treatment with AUVELITY. Elderly patients\nmay be at greater risk. Low sodium levels could be the result of a condition\ncalled syndrome of inappropriate antidiuretic hormone secretion (SIADH).\nTaking AUVELITY with antidepressants called SSRIs may increase the risk. Stop\ntaking AUVELITY and call your HCP or go to the nearest hospital emergency room\nright away if you have any of the following signs or symptoms: headache,\ndifficulty concentrating, memory loss, confusion, weakness and unsteadiness\nwhich can lead to falls.\n\nCOMMON SIDE EFFECTS\n\nThe most common side effects of AUVELITY when treating MDD include dizziness,\nheadache, diarrhea, feeling sleepy, dry mouth, sexual function problems, and\nexcessive sweating.\n\nThe most common side effects of AUVELITY when treating agitation that may\nhappen with dementia due to Alzheimer’s disease include dizziness and\nindigestion.\n\nThese are not all the possible side effects of AUVELITY. Tell your doctor if\nyou have any side effects. You are encouraged to report side effects of\nprescription drugs to the FDA. Visit www.fda.gov/medwatch, or call\n1–800-FDA-1088.\n\nBEFORE USING\n* Tell your HCP about all the medicines you take, including prescription and\nover-the-counter medicines, vitamins, and herbal supplements.\n* It is important to tell your HCP if you are taking: * other medicines\ncontaining bupropion or dextromethorphan\n* medicines to treat depression, anxiety, psychotic or thought disorders,\nincluding selective serotonin reuptake inhibitors (SSRIs) and tricyclic\nantidepressants\n* theophylline\n* corticosteroids\n* oral diabetes medicines or use insulin to control your blood sugar\n* medicines to control appetite (anorectic)\n* nicotine medicines to help you stop smoking\n* street (illicit) drugs\n* benzodiazepines, sedative-hypnotic (sleep medicines), or opiates\n \n* If you are unsure if you take any of these medicines, ask your HCP. They can\ntell you if it is safe to take AUVELITY with your other medicines.\n* Tell your HCP if you are pregnant or plan to become pregnant. AUVELITY may\nharm your unborn baby if you take it during pregnancy. AUVELITY is not\nrecommended during pregnancy. Your HCP will prescribe another treatment for\nfemales who plan to become pregnant.\n* One of the ingredients in AUVELITY passes into your breast milk. Do not\nbreastfeed during treatment with AUVELITY and for 5 days after the final dose.\nTell your HCP about all your medical conditions, including if you:\n* have problems with your liver or kidneys.\n* have diabetes, heart disease, or high blood pressure.\n* have a history of seizure, stroke, eating disorder, head injury, or have a\ntumor in your brain or spinal cord.\n* have a history of alcohol or drug abuse.\n* have a history of seizure, eating disorder, or abuse alcohol or drugs.\n* have low blood sugar, low blood sodium levels, or a history of falls.\n* you take certain other medicines that could interact with AUVELITY.\n* have or had a condition known as bipolar disorder, a family history of\nbipolar disorder, suicide, or depression.\n* have high pressure in the eye (glaucoma).\nReview the list below with your HCP. AUVELITY may not be right for you if:\n* you drink a lot of alcohol.\n* you abuse prescription or street drugs.\n* you are pregnant or plan to become pregnant.\n* you are breastfeeding or plan to breastfeed.\nHOW TO TAKE\n* Take AUVELITY exactly as instructed by your HCP.\n* MDD: Take AUVELITY 45 mg/105 mg once daily in the morning for 3 days. On Day\n4, increase to the maximum recommended dosage of AUVELITY 45 mg/105 mg twice a\nday, taken at least 8 hours apart. Do not take more than 2 AUVELITY tablets in\n24 hours.\n* AAD: * Take 1 AUVELITY 30 mg/105 mg tablet once daily in the morning for 7\ndays.\n* On Day 8, increase to AUVELITY 30 mg/105 mg twice a day, taken at least 8\nhours apart. Do not take more than 2 AUVELITY tablets in 24 hours.\n* On Day 15 after starting AUVELITY, increase to the maximum recommended\ndosage of AUVELITY 45 mg/ 105 mg twice a day, taken at least 8 hours apart,\nbased on tolerability. Do not take more than 2 AUVELITY tablets in 24 hours.\n \n* If you miss a dose, do not take an extra dose. Wait and take your next dose\nat the regular time. Do not take more than 1 dose of AUVELITY at a time.\n* Do not change your dose or stop taking AUVELITY without talking to your HCP.\n* Swallow AUVELITY tablets whole. Do not crush, chew, or divide the tablets.\n* Do not give AUVELITY to other people.\n* If you take too much AUVELITY call your poison control center at\n1-800-222-1222 or go to the nearest hospital emergency room right away.\nLEARN MORE\n\nFor more information about AUVELITY, call 866-496-2976 or visit AUVELITY.com.\n\nThis summary provides basic information about AUVELITY but does not include\nall information known about this medicine. Read the information that comes\nwith your prescription each time your prescription is filled. This information\ndoes not take the place of talking with your doctor. Be sure to talk to your\ndoctor or other HCP about AUVELITY and how to take it. Your HCP is the best\nperson to help you decide if AUVELITY is right for you.\n\nAUVELITY is available as 30 mg dextromethorphan/105 mg bupropion and 45 mg\ndextromethorphan/105 mg bupropion tablets.\n\nAUC CON BS 04/2026\n\nPlease see full Prescribing Information\n(https://www.globenewswire.com/Tracker?data=0l5wIE40rmE9xGJfjJuQDWCuCKqWN2TyCsnOsYO7ESIncqwqkDUVMdZ6XwERo3Sy9Qmlp7vWXFp6ryUMVTJjKs4QilXB65PYxji1OiAUczdqF7wWi5dR23U2NY2udMsJooa0dGN60V38G-zGA7IHlkfI38MC_POIEsyhqRA1Gw5Hd-ivCsHIqWwlw4oBHOGS),\nincluding Boxed Warning for suicidal thoughts and behaviors, and Medication\nGuide\n(https://www.globenewswire.com/Tracker?data=THgpvspI8A7y8hafxrXS0LZET-PkvEuPYMpIUMgG1WA9fUjup_2LYr57Yq3JGwlzbDO0eCBIq2TLywbL_wQkFCa_qjutDDoIC3EOhuKMCC_F3aFlikWRIs-s4jmfBsHmiKLKOYGmAP4HUTJ9PNrUnV5zSUa7agolSKZMzpZ7ecs=).\n\nAbout Axsome Therapeutics\n\nAxsome Therapeutics is a biopharmaceutical company leading a new era in the\ntreatment of central nervous system (CNS) conditions. We deliver scientific\nbreakthroughs by identifying critical gaps in care and develop differentiated\nproducts with a focus on novel mechanisms of action that enable meaningful\nadvancements in patient outcomes. Our industry-leading neuroscience portfolio\nincludes FDA-approved treatments for agitation associated with dementia due to\nAlzheimer’s disease, major depressive disorder, excessive daytime sleepiness\nassociated with narcolepsy and obstructive sleep apnea, and migraine, and\nmultiple late-stage development programs addressing a broad range of serious\nneurological and psychiatric conditions that impact over 150 million people in\nthe United States. Together, we are on a mission to solve some of the\nbrain’s biggest problems so patients and their loved ones can flourish. For\nmore information, please visit us at www.axsome.com and follow us on LinkedIn\n(https://www.globenewswire.com/Tracker?data=MIkG-v4wBZxR6N73NJvVv0wr3_Ml8VZsQrNHO41YRBqWwdFLRhufmlaPESchOOaVuvYBlFJemV0_2JN5viLqcTnyeCeXURtn-G0JQiDyqEo=)\nand X\n(https://www.globenewswire.com/Tracker?data=dMbNclo--mYTB7xEd5sy1LsPRPOto4l4vAkh2Php822oAlGL5WgfhBHa4S5UKjl0AsCXVCod-AvHxU6fGWGUrg==).\n\nForward Looking Statements\n\nCertain matters discussed in this press release are “forward-looking\nstatements”. The Company may, in some cases, use terms such as\n“predicts,” “believes,” “potential,” “continue,”\n“estimates,” “anticipates,” “expects,” “plans,” “intends,”\n“may,” “could,” “might,” “will,” “should” or other words\nthat convey uncertainty of future events or outcomes to identify these\nforward-looking statements. In particular, the Company’s statements\nregarding trends and potential future results are examples of such\nforward-looking statements. The forward-looking statements include risks and\nuncertainties, including, but not limited to, the commercial success of the\nCompany’s SUNOSI(®), AUVELITY(®), and SYMBRAVO(®) products and the\nsuccess of the Company’s efforts to obtain any additional indication(s) with\nrespect to solriamfetol and/or AXS-05; the Company’s ability to maintain and\nexpand payer coverage; the success, timing and cost of the Company’s ongoing\nclinical trials and anticipated clinical trials for the Company’s current\nproduct candidates, including statements regarding the timing of initiation,\npace of enrollment and completion of the trials (including the Company’s\nability to fully fund the Company’s disclosed clinical trials, which assumes\nno material changes to the Company’s currently projected revenues or\nexpenses), futility analyses and receipt of interim results, which are not\nnecessarily indicative of the final results of the Company’s ongoing\nclinical trials, and/or data readouts, and the number or type of studies or\nnature of results necessary to support the filing of a new drug application\n(“NDA”) for any of the Company’s current product candidates; the\nCompany’s ability to fund additional clinical trials to continue the\nadvancement of the Company’s product candidates; the timing of and the\nCompany’s ability to obtain and maintain U.S. Food and Drug Administration\n(“FDA”) or other regulatory authority approval of, or other action with\nrespect to, the Company’s product candidates, including statements regarding\nthe timing of any NDA submission; the Company’s ability to successfully\ndefend its intellectual property or obtain the necessary licenses at a cost\nacceptable to the Company, if at all; the Company’s ability to successfully\nresolve any intellectual property litigation, and even if such disputes are\nsettled, whether the applicable federal agencies will approve of such\nsettlements; the successful implementation of the Company’s research and\ndevelopment programs and collaborations; the success of the Company’s\nlicense agreements; the acceptance by the market of the Company’s products\nand product candidates, if approved; the Company’s anticipated capital\nrequirements, including the amount of capital required for the\ncommercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s\ncommercial launch of its other product candidates, if approved, and the\npotential impact on the Company’s anticipated cash runway; the Company’s\nability to convert sales to recognized revenue and maintain a favorable gross\nto net sales; unforeseen circumstances or other disruptions to normal business\noperations arising from or related to domestic political climate,\ngeo-political conflicts or a global pandemic and other factors, including\ngeneral economic conditions and regulatory developments, not within the\nCompany’s control. The factors discussed herein could cause actual results\nand developments to be materially different from those expressed in or implied\nby such statements. The forward-looking statements are made only as of the\ndate of this press release and the Company undertakes no obligation to\npublicly update such forward-looking statements to reflect subsequent events\nor circumstances.\n\nInvestors:\nAshley Dong\nSenior Director, Investor Relations\n(929) 687-1614\nadong@axsome.com\n\nMedia:\nDarren Opland\nSenior Director, Corporate Communications\n(929) 837-1065\ndopland@axsome.com\n\nReferences:\n1. AUVELITY [Prescribing Information]. New York, NY: Axsome Therapeutics, Inc.\n2. Alzheimer’s Association. 2025 Alzheimer’s Disease Facts and Figures.\n3. Van der Mussele, S. et al. Agitation-associated behavioral symptoms in mild\ncognitive impairment and Alzheimer's dementia. Aging Ment Health.\n2015;19(3):247-57.\n4. Cummings J.L., et al. An overview of the pathophysiology of agitation in\nAlzheimer's dementia with a focus on neurotransmitters and circuits. CNS\nSpectr 2024:1–10.\n5. Rosenberg P.B., et al. Neuropsychiatric symptoms in Alzheimer's disease:\nWhat might be associated brain circuits? Mol Aspects Med 2015;43-44:25–37.\n6. Porsteinsson, A.P. and Antonsdottir, I.M. An update on the advancements in\nthe treatment of agitation in Alzheimer’s disease. Expert Opin Pharmacother.\n2017 Apr;18(6):611-620.\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/1186f248-bfb6-4258-a391-f2ffd94c5d76)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-05-01T11:15:00.188894503Z","server_sent_at_ms":1777634100188},"received_at":"2026-05-01T11:16:11.863Z","source_url":null},"analysis":null,"durationMs":null,"modelName":null}}